Report Forms

What Are Case Report Forms And Where They Are Used

Nowadays, any cure before getting into the market passes through a long series of clinical trials. It is necessary to prove that a certain medicine is able to solve a specific health problem, and to do it more effectively, than its predecessors.

The selection is tight – 98% of all studied drugs do not reach its target client. The last 2% of the successful researches before entering the market spend more than 12 years and 1.5 billion dollars. However, for many patients, a medical test is the only chance to get free treatment for a deadly disease. Therefore, we want as many people as possible to understand: perhaps, they have a chance to get medicaments that can save their lives. This is when the Case Report Forms (CRFs) translation comes in handy. 

 

What Are CRFs? 

This is a paper or e-document intended to collect info about the participant of clinical trials. These forms should comply with the following tasks:

  • establishment of data collection in accordance with the protocol;
  • satisfaction of the requirements for the control and information collection system;
  • complete data processing, their analysis and reporting on the results;  
  • all the data about the participants have to be accurately interpreted. 

Only if it meets the requirements of the trial, it reliably answers questions about the effectiveness and safety of the studied medicines. It is obvious, that people united by the same disease and the goal to overcome it, will travel far away to get a cure. To translate Case Report Forms accurately, the following participant data should be indicated:

  • name;
  • surname;
  • ID;
  • info on inclusion / exclusion criteria;
  • demographic data;
  • detailed dosing of the medicines;
  • cases of adverse reactions (side effects and intercurrent diseases);
  • test report;
  • signature and date.

In addition, the following pages should be provided for inserting the full objective information: disease history, primary diagnosis, previous relevant treatment, initial characteristics, laboratory checks, procedures, etc.

If patients from different countries participate in the research, then the relevant materials are interpreted into a language that they understand and, at the same time, reflect the specifics of the case. Therefore, translators should be not just specialists who are fluent in a foreign language but also have a medical education. They will make the data accessible to patients, on the one hand, and on the other, professionally reflect the results. 

 

In conclusion 

There is no need to despair in case of serious disease – there is possibly a solution for everyone! Participation is the only thing required. Isn’t it good? We believe it is.

2 Comments

Leave a Reply

Your email address will not be published. Required fields are marked *